MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK FASTRACKER? - 325 SYSTEM; AGENTS, EMBOLIC, FOR TREATMENT OF UTERINE FIBROIDS

Model Number M0035503040

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 09/26/2014

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 15dec2014.It was reported that inner package damage occurred.During unpacking, the physician noted that the inner package of the fastracker¿ - 325 system was damaged.The procedure was completed with another of the same device.There were no patient complications reported and the patient¿s condition was stable.However, device analysis revealed that the top seal of the inner pouch had been opened.

Manufacturer Narrative

The complaint device was returned for analysis.Clear tape had been applied on both the top and bottom openings of the box.On opening the box it could be seen that the pouch was open at the top.The pouch was removed from the box and it could be seen that the seal at the top of the pouch had been opened and that the rest of the seal around the package was intact.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

• Brand Name: FASTRACKER? - 325 SYSTEM
• Type of Device: AGENTS, EMBOLIC, FOR TREATMENT OF UTERINE FIBROIDS
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4413966
• MDR Text Key: 5277978
• Report Number: 2134265-2015-00196
• Device Sequence Number: 1
• Product Code: NAJ
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K030966
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2014
• Device Model Number: M0035503040
• Device Catalogue Number: 550304
• Device Lot Number: 15627877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 74